(a) Field of the Invention
This disclosure relates to a pharmaceutical composition simultaneously having a rapid-acting property and a long-acting property. The pharmaceutical composition exhibits independent release properties of an immediate release part and a sustained-release part, and it may be prepared by a relatively simple process without limitation to the composition and the kinds of usable active pharmaceutical ingredients (API).
(b) Description of the Related Art
Currently, according to the progress of preparation technologies, developments of technologies for sustained-release of various drugs are under progress in order to improve compliance of patients. A sustained-release preparation decreases the number of administration while effectively inducing potential effects of drugs by maintaining pharmaceutical effects, compared to an immediate-release preparation, and it has a lot of advantages in terms of effectiveness and safety such as reduction in side-effects or toxicity. However, for analgesics, etc. requiring immediate effects, a rapid acting property of rapidly reaching effective blood concentration to exhibit analgesic effect, etc. after administration is also required. Thus, a development of preparation simultaneously having a rapid-acting property and a long-acting property is required.
A representative preparation simultaneously having a rapid-acting property and a long-acting property includes Tylenol ER currently marketed by Janssen (U.S. Pat. No. 4,820,522), which simultaneously contains a determined drug dose containing a wicking agent and an erosion promoter in an immediate-release drug layer, and a powder composition and a determined drug dose containing an active matrix binder (hydroxyethylcellulose) and a wicking agent (microcrystalline cellulose) in a sustained-release drug layer, and is a dual-layered tablet prepared using a specific tableting machine.
As the existing technologies having the immediate-release part and the sustained-release part, a multi layer tablet prepared by depositing an immediate-release part and a sustained-release part, a core tablet prepared by forming a sustained-release part and then inserting it in an immediate-release part and dually tableting, an osmotic pump tablet, and spherical granules prepared by extrusion and spheronization have been reported.
However, according to the existing technologies, specific equipments are required and the process is complicated. And, since in the existing technologies, both the immediate-release part and the sustained-release part are tableted in the form of a matrix or compression-molded, disintegration or release of the immediate-release part may be delayed due to the base contained in the sustained-release part, and thus, it may be difficult that the immediate-release part and the sustained-release independently exhibit release properties. Furthermore, they are difficult to be applied for a drug requiring high content.